Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/30—Joints
  • A61F2/32—Joints for the hip
  • A61F2/34—Acetabular cups
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/30—Joints
  • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/28—Materials for coating prostheses
  • A61L27/30—Inorganic materials
  • A61L27/306—Other specific inorganic materials not covered by A61L27/303 - A61L27/32
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/28—Materials for coating prostheses
  • A61L27/34—Macromolecular materials
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
  • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/30—Joints
  • A61F2/3094—Designing or manufacturing processes
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/30—Joints
  • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
  • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
  • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
  • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/30—Joints
  • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
  • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
  • A61F2002/3006—Properties of materials and coating materials
  • A61F2002/30065—Properties of materials and coating materials thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
  • A61F2/02—Prostheses implantable into the body
  • A61F2/30—Joints
  • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
  • A61F2002/30769—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth madreporic
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2210/008—Phase change materials [PCM], e.g. for storing latent heat
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
  • A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
  • A61F2310/00389—The prosthesis being coated or covered with a particular material
  • A61F2310/00395—Coating or prosthesis-covering structure made of metals or of alloys
  • A61F2310/00407—Coating made of titanium or of Ti-based alloys
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2400/00—Materials characterised by their function or physical properties
  • A61L2400/14—Adhesives for ostomy devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
  • A61L2420/00—Materials or methods for coatings medical devices
  • A61L2420/04—Coatings containing a composite material such as inorganic/organic, i.e. material comprising different phases

Definitions

• the present invention relates to an orthopedic implant, such as an acetabulum for a hip prosthesis. Furthermore, the present invention relates to a method for making an orthopedic implant, such as an acetabulum for a hip prosthesis.
• the present invention finds particular application in the field of reconstructive surgery and orthopedics, in particular for the manufacture of hip prostheses.
• US5024670 discloses an orthopedic implant and its method of manufacture.
• the implant comprises a polymer substrate having an outer surface to be secured to a bone tissue.
• the outer surface is covered by titanium particles of relatively large size, because their particle size is between 177 ⁇ and 250 ⁇ .
• the present invention aims to solve, in whole or in part, the problems mentioned above.
• the subject of the invention is an orthopedic implant, such as a hip prosthesis acetabulum, the orthopedic implant comprising at least one substrate which comprises at least one polymeric plastic material and which has an external surface intended to be bonded to bone tissue, said outer surface being partially covered by particles of at least one metal material comprising titanium;
• the orthopedic implant being characterized in that said particles comprise primary particles and secondary particles, the primary particles having a particle size ranging between 1 80 ⁇ ⁇ and 600 ⁇ ⁇ , preferably between 200 ⁇ ⁇ and 500 ⁇ , the secondary particles having a particle size ranging between 70 ⁇ and 145 ⁇ , preferably between 90 ⁇ and 125 ⁇ , the primary particles and the secondary particles being distributed relatively uniformly on the outer surface.
• the outer surface is covered with small particles and large particles.
• such a covering makes it possible to increase, or even maximize, the recovery rate and the quantity of interstices, and thus to promote bone growth and the attachment of bone tissue, which leads to a long service life of the bone. prosthesis.
• particle size refers to the particle size or "grain”.
• the particle size is conventionally characterized by a particle size characteristic of a numerical distribution of the particles of a set as a function of the size of each particle.
• the outer surface may be partially covered by other particles, metallic or not, and having a distinct particle size, for example intermediate between those of the primary and secondary particles.
• said polymeric plastic material is selected from the group consisting of a polyethylene (PE), a polyethylene with a very high molecular weight
• UHMW-PE highly crosslinked polyethylene
• XLPE highly crosslinked polyethylene
• PEEK polyetheretherketone
• such a polymeric plastic material makes it possible to produce a biocompatible substrate that is light and mechanically and chemically resistant.
• the or each metallic material is selected from the group consisting of pure titanium, an alloy of chromium titanium, cobalt and stainless steel such as 316LVM steel.
• Such a metal matrix makes it possible to promote the attachment of growing bone tissue around the external surface.
• the primary particles and the secondary particles are composed of the same metallic material.
• such primary particles and secondary particles can be implemented in the same way, for example at the same temperature and / or at the same pressure.
• the area of the part of the external surface that is not covered by said particles represents between 15% and 30%, preferably between 20% and 25%, of the surface area. total of the external surface.
• the degree of coverage of the external surface by the metallic material is between 60% and 80%, preferably between 65% and 75%.
• a coverage rate allows the attachment and growth of many bone tissues, which is not the case when the metal particles are too small and induce a too high coverage rate.
• the primary interstices between primary particles have approximately equal areas.
• interstices allow the implantation of secondary particles, smaller, which ensures uniform distributions of primary and secondary particles on the outer surface.
• the term "approximately equal” indicates for example that the areas of the primary interstices vary by plus or minus 20% from their median.
• the number of primary particles is substantially between 5% and 50%, preferably between 10% and 30%, of the sum of the number of primary particles and the number of secondary particles.
• the sum of the number of primary particles and the number of secondary particles corresponds globally to the total number of particles.
• the number of secondary particles is substantially between 95% and 50%, preferably between 70% and 30%, of the sum of the number of primary particles and the number of secondary particles.
• the outer surface generally has the shape of a spheroidal portion, preferably in the form of a half-sphere.
• a hemispherical outer surface makes it possible to achieve an isotropic attachment, that is to say a hooking resistant to forces exerted in different directions.
• the orthopedic implant has a single monoblock substrate.
• the subject of the present invention is a method for producing an orthopedic implant, such as an acetabulum for a hip prosthesis, the orthopedic implant comprising at least one polymeric plastic material having an external surface designed to be secured to a patient. bone tissue, the method comprising the steps of:
• secondary particles of at least one metallic material comprising titanium the secondary particles having a particle size ranging from 70 ⁇ to 145 ⁇ , preferably from 90 ⁇ ⁇ to 1 25 ⁇ , the secondary particles being distributed relatively uniformly on the outer surface; and pressing the heated matrix against the outer surface, so as to secure the secondary particles to the outer surface.
• such a method makes it possible to manufacture an orthopedic implant according to the invention in a reliable and rapid manner.
• such a method does not implement plasma deposition, particularly energy-consuming and random.
• the step of covering the outer surface with the primary particles is performed before the step of covering the outer surface with the secondary particles.
• the second (small) regions supplement the vacant sites by the (large) primary particles.
• the primary particles and the secondary particles are premixed in order to form a homogeneous powder, and in which the step of covering the outer surface with the primary particles is carried out simultaneously at the step of cover of the outer surface by the secondary particles.
• the step of covering the outer surface with the primary particles and the step of covering the outer surface with the secondary particles are carried out by placing them in contact in a closed space. pressurized and heated to a temperature below the melting temperature of the polymeric plastic material.
• FIG. 1 is a perspective view of an orthopedic implant in accordance with the invention
• FIG. 2 is a perspective view, truncated along the plane II in FIG. 1 and at a different angle to FIG. 1, of the orthopedic implant of FIG. 1;
• Figure 3 is a top view of the orthopedic implant of Figure 1;
• FIG. 4 is a microscopic photograph of a portion of the orthopedic implant of FIG. 1;
• Figure 5 is a microscopic photograph, at half of the scale of Figure 4, of a portion of the orthopedic implant of Figure 1;
• FIG. 6 is a schematic view illustrating a step of a method according to the invention for manufacturing the orthopedic implant of FIGS. 1 to 5.
• Figure 1 shows an orthopedic implant 1, which forms an acetabulum for a hip prosthesis.
• the orthopedic implant 1 is an acetabular implant.
• the orthopedic implant 1 comprises a substrate 2 comprising at least one polymeric plastic material.
• the orthopedic implant 1 comprises only the substrate 2, which is monobloc.
• the polymeric plastic material forming the substrate 2 is a high density polyethylene (HDPE).
• HDPE high density polyethylene
• this polymeric plastic material may be selected from the group consisting of high density polyethylene (PEH D), highly crosslinked polyethylene (XLPE), polyurethane and polyetheretherketone (PEEK).
• the substrate 2 has an outer surface 3 which is intended to be secured to a bone tissue belonging to the iliac bone not shown.
• the outer surface 3 has the overall shape of a half-spheroid or even a half-sphere, intended to be incorporated into the iliac bone.
• the outer surface 3 has a diameter of about 50 mm. Alternatively, the diameter of the outer surface can be selected between 40 mm and 70 mm.
• the substrate 2 also has an inner surface 4 located opposite the outer surface 3.
• the inner surface 4 forms an acetabular surface, for the articulation of a femoral head not shown.
• the outer surface 3 is partially covered by particles of a metallic material composed here of pure titanium.
• the or each metallic material may be a titanium alloy, thus a material comprising titanium and another metallic or nonmetallic material, for example chromium, cobalt and stainless steel such as steel 6LVM.
• chromium, cobalt and stainless steel such as steel 6LVM.
• stainless steel such as steel 6LVM.
• such alloys are defined in ISO 5832.
• Part of the outer surface 3 is not covered by the particles 5.
• the area of this portion of the outer surface 3 not covered by the particles 5 represents about 25% of the total area of the outer surface 3. In part other words, the particles cover about 75% of the total area of the outer surface 3.
• the total area of the outer surface 3 is about 3930 mm 2 , while the area of this portion of the outer surface 3 uncovered.
• the particles 5 mainly comprise primary particles 51 and secondary particles 52.
• the primary particles 51 and the secondary particles 52 are composed of the same metallic material, titanium pure.
• the number of primary particles 51 is substantially between 5% and 50%, preferably between 10% and 30%, of the sum of the number of primary particles 51 and the number of secondary particles 52, i.e. approximately to the total number of particles 5.
• the number of secondary particles 52 represents substantially between 95% and 50%, preferably between 70% and 30%, of the sum of the number of primary particles 51 and the number of secondary particles 52.
• the total mass of primary particles 51 and secondary 52 may be for example between 4 g and 20 g.
• the primary particles 51 have a particle size extending substantially between 200 and 500 m.
• the secondary particles 52 have a particle size extending substantially between 90 ⁇ and 125 ⁇ . In practice, the primary particles 51 have a particle size extending substantially between 180 m and 600 ⁇ . In practice, the secondary particles 52 have a particle size extending substantially between 70 ⁇ and 145 ⁇ .
• the primary particles 51 and secondary particles 52 are distributed relatively uniformly over the outer surface 3. Thus, the primary interstices between primary particles 51 have approximately equal areas. These primary interstices house the secondary particles 52.
• a method according to the invention, for manufacturing the orthopedic implant 1 comprises the steps:
• HDPE high density polyethylene
• such a manufacturing method comprises the steps of:
• the step of covering the outer surface 3 with the primary particles 51 is carried out before the step of covering the outer surface 3 with the secondary particles 52.
• the primary particles and the secondary particles can be premixed to form a homogeneous powder.
• the step of covering the outer surface with the primary particles can be carried out simultaneously with the step of covering the outer surface with the secondary particles.
• the step of covering the outer surface with the primary particles and the step of covering the outer surface with the secondary particles are carried out by contacting in the closed volume of the mold 101 which is pressurized and heated to a temperature less than the melting temperature of the polymeric plastic material.
• dies 1 02 and 1 03 may exert pressures P 1 02 and P 1 03 on the mold 1 01.
• a spacer 104 distributes the pressures P1 02 and P103.
• the orthopedic implant 1 forms a hip prosthesis acetabular implant acetabulum.
• the orthopedic implant 1 is secured to a bone tissue belonging to the iliac bone not shown.
• the articulation of the femoral head is on the inner surface 4.

Landscapes

• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Veterinary Medicine (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Chemical & Material Sciences (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Epidemiology (AREA)
• Medicinal Chemistry (AREA)
• Dermatology (AREA)
• Engineering & Computer Science (AREA)
• Vascular Medicine (AREA)
• Heart & Thoracic Surgery (AREA)
• Biomedical Technology (AREA)
• Cardiology (AREA)
• Inorganic Chemistry (AREA)
• Prostheses (AREA)
• Materials For Medical Uses (AREA)

Priority Applications (5)

Applications Claiming Priority (2)

Publications (1)

Family

ID=47901194

Family Applications (1)

Country Status (7)

Cited By (1)

Families Citing this family (3)

Citations (4)

Family Cites Families (11)

• 2012
  • 2012-02-20 FR FR1251516A patent/FR2986961B1/fr active Active
• 2013
  • 2013-02-19 AU AU2013223905A patent/AU2013223905B2/en not_active Ceased
  • 2013-02-19 EP EP13710481.6A patent/EP2816974B1/fr not_active Revoked
  • 2013-02-19 JP JP2014557114A patent/JP6170949B2/ja active Active
  • 2013-02-19 WO PCT/FR2013/050336 patent/WO2013124577A1/fr active Application Filing
  • 2013-02-19 IN IN7040DEN2014 patent/IN2014DN07040A/en unknown
  • 2013-02-19 US US14/377,671 patent/US9724199B2/en active Active

Patent Citations (4)

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